BioZorb Complications & Side Effects
BioZorb Lawsuit Team Lead
Founding Attorney
This is an active lawsuit and none of the allegations against the defendant(s) have been proven. The contents of this page reflect the allegations in the litigation.
BioZorb markers are used to help guide radiation therapy for breast cancer patients. These medical devices are supposed to reabsorb into the body after use. However, they reportedly often do not dissolve as they should, which can potentially result in many serious complications and side effects.
If you or a loved one has suffered because of a BioZorb marker, you should talk to a lawyer promptly. At Oberheiden Law Group, our lawyers are ready to fight for you and seek the compensation you deserve.
What Types of Complications Can BioZorb Markers Cause?
Individuals alleging harm from defective BioZorb markers are currently suing the manufacturer, Hologic, Inc. to seek financial compensation for various complications. The company issued a recall for its BioZorb markers in early 2024.
The U.S. Food and Drug Administration (FDA) classified the BioZorb marker recall as a Class I recall, which means these implants have the potential to cause “serious adverse health consequences or death.” The FDA has received reports describing the following BioZorb complications:
- Infection
- Seroma (fluid buildup)
- Migration (device moving out of position)
- Erosion (device breaking through the skin)
These are the main complaints seen by the FDA. However, patients and families may be able to pursue claims for other complications as well.
Infections
Inserting a BioZorb marker in the breast tissue can introduce bacteria or other microorganisms into the surgical site. Migration and erosion can also cause an infection. If an implantable breast tissue marker migrates or erodes through the skin, this can present an infection risk as well.
Additionally, when an implanted BioZorb marker is not properly reabsorbed in the soft tissue, the body’s immune system may react to the marker as a foreign object, leading to inflammation and potentially increasing the risk of infection.
Seroma
The body’s immune system may recognize the marker as a foreign object and respond by producing inflammatory cells and fluid. This can lead to the formation of a seroma, which is a fluid-filled sac that may develop after surgery.
The insertion of the marker can cause minor trauma to the surrounding soft tissue. This trauma can stimulate the production of inflammatory cells and fluid, also contributing to seroma formation.
In some cases, the marker may migrate or erode through the skin, creating an opening for fluid to accumulate. This can increase the risk of seroma formation.
Migration and Erosion
BioZorb markers are designed to be absorbed by the body over time, but in some cases, they reportedly may migrate or erode. Over time, the body’s natural processes, such as tissue growth and healing, can cause the marker to shift or become dislodged.
If the body experiences inflammation or infection around the marker, this can weaken the surrounding tissue, making it more susceptible to erosion. External factors, such as pressure or movement, can also contribute to the migration or erosion of the marker.
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What BioZorb Side Effects Should I Look For?
As reported by the FDA, the potential complications of BioZorb implants are serious and can lead to adverse health consequences, and can potentially be fatal in some cases. There are some side effects that you should look for that may indicate you are experiencing adverse events of an implanted BioZorb marker.
Some of the side effects patients may experience include:
- Infection: Fever, fatigue, loss of appetite, body aches, pain, chills, sweating, rash.
- Seroma: Buildup of fluid, pain, swelling, discomfort, limited range of motion.
- Migration and Erosion: Pain, discomfort (feeling the device in the breast), swelling, drainage of fluid or pus, skin changes, redness, irritation, discoloration, limited range of motion, sensitivity.
Extended resorption time of a BioZorb marker can reportedly lead to complications due to increased exposure of the marker, which is made of biodegradable polymers, to the body. As the marker remains in the body for a longer period, there may be a greater chance of adverse reactions, such as inflammation, migration, or erosion.
Additionally, prolonged exposure can increase the risk of infection. All of these reported complications can cause pain and discomfort and potentially require future medical procedures.
Complications from BioZorb Markers Could Delay Breast Cancer Treatment
In addition to serious adverse health effects, such as infection, seroma, migration, and erosion, problems with a BioZorb marker may result in the need to stop or delay treatment for breast cancer.
Stopping or delaying breast cancer treatment due to health issues caused by a BioZorb marker could have serious consequences. The cancer may continue to grow, making it more difficult to treat. The cancer may also spread (or metastasize) to other parts of the body, making it harder to control and increasing the risks involved. The effectiveness of certain breast cancer treatments may also decrease if they are not started or continued in a timely manner.
FDA: BioZorb Complications May Lead to Death
As reported by the FDA, complications associated with BioZorb markers may lead to death in some cases. Severe infections and required delays in cancer treatment, as well as other complications, can be potentially life threatening.
If a BioZorb marker causes an infection and the infection spreads rapidly, it can lead to sepsis, a life-threatening condition characterized by a whole-body inflammatory response. Sepsis can cause organ failure, leading to death.
Additionally, if the BioZorb marker migrates or erodes into the chest cavity or blood vessels, it can cause bleeding. In severe cases, this may lead to significant blood loss and death.
Contact a BioZorb Lawsuit Lawyer Today for Help
If you or a loved one has been harmed by BioZorb marker, you may be eligible to receive compensation for your losses. When you contact a BioZorb lawyer at Oberheiden Law Group, your lawyer will discuss your options and help you make informed decisions about what to do next. For a free, no-obligation consultation, call 866-781-9539 or get in touch online today.
Further Information About Our BioZorb Lawsuit Services
- BioZorb Lawsuit
- BioZorb FDA Warning & Recall Information
- Do I Need a BioZorb Lawyer to File a Lawsuit?
- BioZorb Lawsuit Settlement Amounts
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